1. Field of the Invention
This invention relates in general to certain new and useful improvements in method and apparatus for aiding in the reduction of the incidence of smoking, and more particularly, to a method and an apparatus which enables either the transdermal application of nicotine, or the oral administration of nicotine, or both in combination, to reduce the incidence of tobacco smoking.
2. BRIEF DESCRIPTION OF THE PRIOR ART
In recent years, with the recognition of the harmful effects of tobacco smoking, there have been numerous campaigns and programs by governmental agencies and various health groups and other interested organizations to disseminate information about the adverse health effects resulting from tobacco smoking. Moreover, and as a result of this recognition of the harmful effects, there have been many programs directed to attempts in reducing smoking incidence.
The present successes in achieving reduction in the incidence of smoking have been relatively poor with presently known techniques. The present state of the art involves both behavioral approaches and pharmacological approaches. Approximately 80% or more of the tobacco smokers who initially quit smoking after using some behavioral or pharmacological approach to singly reduce smoking incidence generally relapse and return to the habit of smoking at their former rate of smoking within about a one year's period of time.
One of the most successful approaches to date in reducing the incidence of smoking relies upon nicotine containing chewing gum which is designed to reduce smoking withdrawal symptoms. The reported success rate, while still relatively low is approximately twice that of the other methods which have heretofore been employed. The use of the nicotine gum suffers from several problems including not only the bad taste and destruction of dental appliances, but the gastrointestinal upset which results therefrom and which also reduces compliance. In addition, it has been found that the nicotine containing gum does not satisfy the craving that most smokers experience for the distinct sensations in the throat and chest elicited by nicotine in the smoke. Over the course of many years of tobacco smoking, these particular sensations have become an important part of and associated with the habit of smokers and give rise to tobacco smoke dependency in most of the tobacco smokers.
Transdermal administration of various drugs has been well known studies and includes the transdermal administration of cortisol, nitroglycerine and scopolamine. The latter two drugs are commercially available in the form of patches which are releasably applied to the skin for delivering controlled amounts of the drug. Transdermal drug administering patches of this type have been taught, for example, in U.S. Pat. No. 4,336,243 to Sanvordeker et al, U.S. Pat. No. 4,286,592 to Chandrasekaran, U.S. Pat. No. 3,731,683 to Zaffaroni and U.S. Pat. No. 3,797,494 to Zaffaroni.
The effects of using nicotine containing gum were described in detail in the British Medical Journal, Volume 286, dated Feb. 19, 1983. In addition, the nicotine absorption from tobacco leaves is well known. Farmworkers who hand harvest tobacco are at a serious risk of developing a self-limited illness often known as "green tobacco sickness". Although mortality and long-term sequelae have not been associated with this syndrome, it is still responsible for discomfort and a substantial amount of lost work time. The use of protective clothing as a means to reduce body absorption of nicotine is set forth in the Archives of Environmental Health, March/April 1979, pages 111-113.
In addition to the above, the circulatory effects of nicotine aerosol inhalations have been studied as set forth in the Oct. 7, 1967 edition of the Lancet, pages 754-755. In this case, large doses of nicotine aerosols were applied to selected individuals in order to determine the effects on the individuals. Further, circadian blood nicotine concentrations have been studied as a result of cigarette smoking, as reported in Clinical Pharmacology and Therapeutics, December 1982 in an article by Neal L. Benowitz, M.D., pages 758-764.
A simulated smoking device which uses a source of a vaporizable nicotine is disclosed in U.S. Pat. No. 4, 284,089 to Ray. While the cigarette itself is non-combustible, and delivers a vapor, it may not raise the nicotine level in the blood sufficiently to satisfy a smoker. Thus, it has not been shown to satisfy the desire for a certain nicotine level in the blood to which many smokers have become accustomed and, even more so upon which many smokers have become dependent. In addition, the simulated smoking devices of the type taught in U.S. Pat. No. 4,284,089 also suffer from the bad taste of a substantial amount of nicotine introduced into the oral cavity. More importantly, this nicotine does not penetrate into the chest for stimulating and providing that sensation normally provided by nicotine and to which the smoker has become accustomed.
Heretofore, there has not been any attempt to transdermally administer nicotine to an individual in order to aid in the reduction of tobacco smoking. Moreover, there has not been any reported method of reducing the incidence of tobacco smoking by using a selected type of nicotine containing aerosol spray. In addition, there has not been any reported method or apparatus for reducing the incidence of tobacco smoking by using a combination of the aerosol spray and the transdermal administration of nicotine.